关键词: MCED cancer insurance coverage and reimbursement multicancer early detection payer coverage decision making

来  源:   DOI:10.1093/haschl/qxad005   PDF(Pubmed)

Abstract:
Emerging blood-based multicancer early-detection (MCED) tests may redefine cancer screening, reduce mortality, and address health disparities if their benefit is demonstrated. U.S. payers\' coverage policies will impact MCED test adoption and access; thus, their perspectives must be understood. We examined views, coverage barriers, and evidentiary needs for MCED from 19 private payers collectively covering 150 000 000 enrollees. Most saw an MCED test\'s potential merit for cancers without current screening (84%), but fewer saw its merit for cancers with existing screening (37%). The largest coverage barriers were inclusion of cancers without demonstrated benefits of early diagnosis (73%), a high false-negative rate (53%), and lack of care protocols for MCED-detected but unconfirmed cancers (53%). The majority (58%) would not require mortality evidence and would accept surrogate endpoints. Most payers (64%) would accept rigorous real-world evidence in the absence of a large randomized controlled trial. The majority (74%) did not expect MCED to reduce disparities due to potential harm from overtreatment resulting from an MCED and barriers to downstream care. Payers\' perspectives and evidentiary needs may inform MCED test developers, researchers producing evidence, and health systems framing MCED screening programs. Private payers should be stakeholders of a national MCED policy and equity agenda.
摘要:
新兴的基于血液的多癌症早期检测(MCED)测试可能会重新定义癌症筛查,降低死亡率,并解决健康差异,如果他们的利益得到证实。美国付款人的覆盖政策将影响MCED测试的采用和访问;因此,他们的观点必须得到理解。我们研究了观点,覆盖障碍,以及19个私人付款人对MCED的证据需求,总计涵盖15万加入者。大多数人在没有当前筛查的情况下看到了MCED测试对癌症的潜在价值(84%),但较少的人看到其对现有筛查的癌症的价值(37%)。最大的覆盖障碍是包括没有证明早期诊断益处的癌症(73%)。高的假阴性率(53%),以及缺乏MCED检测到但未经证实的癌症的护理方案(53%)。大多数(58%)不需要死亡证据,并接受替代终点。在没有大型随机对照试验的情况下,大多数付款人(64%)会接受严格的现实证据。大多数(74%)并不期望MCED减少由于MCED引起的过度治疗的潜在危害以及下游护理的障碍而导致的差异。付款人的观点和证据需求可能会通知MCED测试开发人员,研究人员提供证据,和卫生系统制定MCED筛查计划。私人付款人应该是国家MCED政策和公平议程的利益相关者。
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